Catheters and related equipment

ABSTRACT

A device for inserting a catheter into a blood vessel that uses fluid flow to aid the insertion of the catheter into a patient is described herein. The device includes a catheter retention device that houses a catheter and is configured to attach to an angiocatheter or other blood vessel access device. The catheter retention device receives fluid and guides the catheter into the blood vessel using the flow of fluid to carry the catheter into the blood vessel.

RELATED APPLICATIONS

This application is continuation-in-part application of U.S. applicationSer. No. 12/297,637 filed Oct. 17, 2008, which is a national phaseapplication of International Application No, PCT/US07/66930 filed Apr.19, 2007, and entitled “Central Venous Catheters and Related Equipment,”which claims the benefit of U.S. Provisional Application No. 60/794,051,filed Apr. 21, 2006, the contents of all of which are herebyincorporated by reference in their entirety.

BACKGROUND

Catheters have long been used for injecting fluids into the centralvenous circulation. Needles and relatively short peripherally insertedvenous catheters (PIVC) are used for routine blood draws and fluidadministrations. Central catheters discharge fluids centrally in thevenous vasculature, and are commonly used for administering drugs thatare too damaging to the veins to administer peripherally, for example,some chemotherapy, antibiotics, and parenteral nutrition. If thecatheter and/or the veins are large enough and strong enough, they canbe used for the rapid injection of contrast agents for imagingprocedures such as, for example, CT, MR, ultrasound, and molecularimaging studies. PIVC lines are generally inexpensive and can be placedor installed by normal nurses or in some cases by specially trainedphlebotomists.

Longer central catheters and infusion ports are, generally, placed intoveins in the chest or neck and usually require surgery to be insertedinto the vein. More recently, long flexible catheters generally referredto as peripherally inserted central catheter (PICC) have replacedinfusion ports that are surgically implanted. These PICC lines can beinserted through a vein in the arm into the central venous circulationnear the heart by trained nurses providing a more economic and patientfriendly means for inserting a central catheter or infusion port.Generally, a guide wire is provided in the lumen of the flexiblecatheter to provide rigidity during the insertion procedure and a stiffneedle, optionally with a dilator, is used to gain access to the vessel.The insertion procedure is carried out using a fluoroscope (or anultrasonic imaging device) to help the user guide the catheter throughthe vessel into the central vena cava and to confirm proper placement ofthe catheter tip. Once in place, the needle or guide wire is removed,leaving the flexible catheter with the distal tip properly positionedfor injection of fluid. These catheters can be left in place for days tomonths for the low flow-rate infusion of medication into the patient,and/or for sampling blood in patients with veins that have beencompromised by disease or by the corrosive effects of chemotherapeuticdrugs. The issues with PICC placement, phlebitis, and irritation ordamage to the vessels and/or the heart have been made worse to someextent by the increased use of Power PICCs which can accommodate thepressures generated during the injection of CT contrast. This is becausethey often are made of a stiffer, stronger plastic and similarly may belarger in size to provide sufficient flow rates for the use in imagingprocedures.

However, insertion of a PICC line has several challenges and drawbacks.The long, relatively stiff catheter and/or guide wire requires thecreation and maintenance of a large sterile field around the insertionpoint so as to not contaminate the catheter or guidewire beforeinsertion into the body. During insertion, the PICC line can catch onvalves and tight bends in blood vessels, potentially causing trauma toblood vessels. In addition, because of the sometimes tortuous path ofthe veins, it can be difficult to move or remove the guidewire relativeto the catheter during installation or when installation is complete.Similarly, a stiff tip on the PICC line can irritate a patient's heartif the PICC line is inserted too far or damage the superior vena cava ifnot inserted far enough. If the catheter is too large or stiff, it candamage the peripheral vein through which passes. This can lead tocomplications such as thrombosis, pain, and infection. Because of theimportance of the correct placement of the catheter tip, the procedurewas historically done under fluoroscopy in an interventional suite. Atthe location where the catheter exits the patient's skin, the stiffnessof the catheter also increases the likelihood of motion and disruptionof the seal between the catheter and the skin which can increase thepossibility of infection.

SUMMARY OF THE INVENTION

The embodiments described herein provide one or more peripherallyinserted central access catheters with one or more lumens which minimizetrauma to the vessels. The controlled delivery of fluid may be used tohelp urge the catheter distally and/or to dilate the vein for easierinsertion. Optionally it provides one or more proximally dischargedlumens which optionally have the capability for accommodating the powerinjection for venous drug injections commonly used as part of an imagingprocedure. Optionally the central access catheter can be insertedthrough an existing peripheral access device which can remain in placeor be removed.

Some embodiments are directed to a catheter retention device thatincludes a catheter retention body having a proximal and a distal end,the catheter retention body defining a lumen designed and configured toreceive a catheter; at least one distal lateral fitting on a distalportion of the catheter retention body, the lateral fitting beingdesigned and configured to couple to a fluid source and introduce fluidinto the distal portion of the lumen of the catheter retention body; anda distal fitting at a distal end of the catheter retention body, thedistal fitting defining an aperture through which fluid and a catheterexit the lumen of the catheter retention body. In such embodiments,fluid flowing through the aperture may provide substantially all of theforce required to expel the catheter from the catheter retention body.

Other embodiments are directed to a multi-port introducer including anintroducer tube, designed and configured to be inserted into a bloodvessel, the introducer tube having an opening with a diameter sufficientto accommodate a catheter and allow fluid delivery through theintroducer tube during deployment of the catheter; a multi-port fittinghead operably connected to the introducer tube; a first fitting operablyconnected to the multi-port introducer, the first fitting configured toprovide a substantially straight path from a proximal opening of thefirst fitting to the opening in the distal end of the introducer tube;and one or more second fittings operably connected to a lateral portionof the multi-port introducer.

Still other embodiments are directed to methods for introducing acatheter into a blood vessel, the methods include the steps ofintroducing an angiocatheter into a blood vessel; and simultaneouslyintroducing fluid and a catheter into the blood vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols typically identify similar components unless contextdictates otherwise. The illustrative embodiments described in thedetailed description, drawings, and claims are not meant to be limiting.Other embodiments may be utilized and other changes may be made, withoutdeparting from the spirit or scope of the subject matter presentedherein. It will be readily understood that the aspects of the presentdisclosure, as generally described herein and illustrated in theFigures, can be arranged, substituted, combined, separated, and designedin a wide variety of different configurations, all of which areexplicitly contemplated herein.

FIG. 1 is an illustration of an angiocatheter.

FIG. 2A is an illustration of a catheter retention device.

FIG. 2B is an illustration of a catheter retention device attached to anangiocatheter.

FIG. 3A is an illustration of a catheter retention device showing thelocation of exemplary fittings.

FIG. 3B is an illustration of a catheter retention device showing thelocation of exemplary fittings and valves.

FIG. 4A is an illustration showing a catheter retention device having acatheter wound within the lumen.

FIG. 4B is an illustration showing a catheter retention device having acatheter folded within the lumen.

FIG. 4C is an illustration showing a catheter retention device having acatheter wound in a spherical catheter retention device.

FIG. 4D is an illustration showing a catheter retention device having acatheter wound in a spherical catheter.

FIG. 5 is an illustration showing an exemplary catheter.

FIG. 5A is an illustration of a cross-section of a single lumencatheter.

FIG. 5B is an illustration of a cross-section of a double lumencatheter.

FIG. 6 is an illustration of a catheter showing the locations ofexemplary lateral slits.

FIG. 7 is an illustration of a multi-port introducer and a needledeployment device.

FIG. 8 is an illustration of a multi-port introducer connected to acatheter retention device.

FIG. 9 is a schematic diagram showing an exemplary control system fordeploying a catheter.

DETAILED DESCRIPTION

As used in this document, the singular forms “a,” “an,” and “the”include plural references unless the context clearly dictates otherwise.Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. Nothing in this document is to be construed as an admissionthat the embodiments described in this document are not entitled toantedate such disclosure by virtue of prior invention.

This disclosure is not limited to the particular systems, devices andmethods described, as these may vary. The terminology used in thedescription is for the purpose of describing the particular versions orembodiments only, and is not intended to limit the scope.

The word “proximal” refers to a direction relatively closer to aclinician using the device described herein, and the word “distal”refers to a direction relatively further from the clinician. Forexample, the end of a catheter placed within the body of a patient isconsidered a distal end of the catheter, while the catheter endremaining outside the body is a proximal end of the catheter.

Embodiments of the invention include devices useful for inserting acatheter into a blood vessel that provide for flow of fluid into theblood vessel simultaneously with insertion of the catheter. Simultaneousfluid flow with the insertion of a catheter allows the catheter to becarried into the blood vessel with the flow of fluid without need for asignificant force from the back or distal end pushing the catheter intothe blood vessel. In addition, the influx of fluid during insertionincreases the blood volume in the blood vessel, expanding and openingthe vein to facilitate insertion and centrally directed movement, andthe flow rate of the blood through the vessel thereby providingsufficient blood flow to carry the catheter through the circulatorysystem without the need to provide a proximally directed force bydistally pushing the catheter into the blood vessel. Once in the vessel,the catheter proceeds through the blood vessel at about the same rate asthe flow rate of the blood or slower, so that there is a proximallydirected force at the tip and optionally over much of its length causedby drag as the fluid moves past the catheter, reducing the likelihood ofkinking that can happen when the catheter exceeds the velocity of theblood and the body of the catheter pushes past the tip during insertion.

The need for guidewires and other stiffening means associated with thecatheter during insertion is also reduced or eliminated as well asallowing catheters to be prepared from softer or more flexible materialssuch as silicones or softer polyurethanes, or have smaller outsidediameter and thinner walls than is possible using catheters and methodsof the prior art. Reducing or eliminating the need for guidewires alsoallows for the use of coated or multi-layer catheter tubes. For example,in certain embodiments, the catheter may be coated or include a layer ofhydrophobic drugs on the inner surface of the catheter while the outersurface can be chosen from materials that are compatible with the bloodor that include, for example, a coating of anti-coagulant oranti-fibrotic drug. Eliminating guidewires also allows for variation inthe diameter of the inner and outer diameter and variation in thematerial stiffness over the length of the catheter. For example, in someembodiments, the diameter of the catheter may be decreased relative tothe body of the catheter to reduce the likelihood of trauma caused bythe tip or reduce the total volume of fluid in the lumen.

Additional embodiments are directed to catheters having a variety of newfeatures, catheter retaining devices that allow coiled catheters to becontained within a shortened sterile housing before, during, and afterinsertion of the catheter into the blood vessel, and methods for usingthe insertion devices, catheters, and catheter retaining devices.Various such embodiments may allow for a reduced sterile field size,enable accurate tip placement by making it easier to adjust the locationof the catheter tip in both upstream and downstream directions, andreduce the need for cutting of the catheter to the appropriate lengthbefore insertion into the vein.

The devices of various embodiments include a means for introducing fluidinto the blood vessel while simultaneously inserting a catheter into ablood vessel. Means for introducing fluid into a blood vessel are wellknown and used in the art. For example, short peripherally insertedcatheters, angiocatheters, are commonly used to introduce intravenous(IV) fluids into a blood vessel. As depicted in FIG. 1, suchangiocatheters 10 generally include a short insertion tube 102 having anangled, conical, or tapered distal end 104, and a venturi feature orother tapered portion 106 that connects the short insertion tube 102 toa body 108. The body 108 generally includes a proximal fitting 110 thatallows the angiocatheter 10 to be connected to tubing associated withfluid source such as an IV bag or syringe for infusion of a drug orother agent. A needle, not shown, extends through the lumen of tube 102and is use to puncture the skin, tissue and blood vessel wall. Once inthe vessel, the tube 102 is pushed over the needle into the vessel andthe needle is withdrawn and discarded.

Certain embodiments of the invention include catheter retaining devicesthat are configured to attach to the fitting of angiocatheters or shortperipherally inserted venous catheters (PIVC) like the angiocatheter 10illustrated in FIG. 1. The ability to deliver a longer catheter throughan existing angiocatheter without having to make a new IV stick mayprovide a benefit in some emergency and critical care situations or inpatients where finding a vein is difficult.

As illustrated in FIG. 2A such catheter retaining devices 21 may includea catheter retention body 220 having a lumen sized and shaped to hold acentral catheter 240, a distal fitting 222 configured to attach to thefitting of an angiocatheter, and one or more lateral fittings 224configured to attach to a fluid source. In some embodiments, the lateralfitting 224 may be at a distal portion of the catheter retention body220. FIG. 2B shows the catheter retaining device 21 attached to a commonangiocatheter 20. In operation, fluid may enter the catheter retentionbody 220 through the lateral fitting 224. The air in the catheterretaining body 220 can exit through distal fitting 222 prior to beingconnected to the angiocatheter 20. After air has been removed and fluidhas accumulated in the catheter retention body 220, it can be connectedto angiocatheter 20, and the fluid will flow through the distal fitting222 into the angiocatheter 20 through the proximal fitting 210 and theangiocatheter body 208. The fluid will exit the angiocatheter 20 andenter the blood vessel through the distal end 204 of the insertion tube202. The flow of fluid through the devices will provide a pulling forceon the catheter 240 related to the velocity or flow rate of the fluidflow. As the rate increases, the force will be sufficient to overcomethe static friction holding the catheter in place and begin drawing thecatheter from the catheter retention body 220 and into the blood vesselwhere blood flow enhanced by the additional fluid from the device willcarry the catheter through the circulatory system to the site ofdeployment.

The catheter retaining devices of various embodiments may include anynumber of additional features necessary to control flow of fluid throughthe device, remove unwanted air or fluid from the central lumen of thecatheter retention body 220, control deployment rate or velocity of thecatheter 240, and direct the catheter through the catheter retainingdevice. For example as illustrated in FIG. 3A, in some embodiments, thecatheter retaining device 31 may include one or more lateral fittings inaddition to the distal lateral fitting 324 located along the catheterretention body 320, and in certain embodiments, a second lateral fitting324 a may be positioned on a proximal portion of the catheter retentionbody. In such embodiments, the second lateral fitting 324 a may providean additional means for introducing fluid into the catheter retentionbody 320. Alternatively or in addition, the second lateral fitting 324 amay be on a distal portion of the catheter retention body 320 or theangiocatheter body so that fluid flowing through it exerts little or noforce on the catheter while in the catheter retention body 320 or theangiocatheter body and flows into the vessel to distend and/or augmentthe flow in the vessel. The second lateral fitting may further provide ameans for allowing air or fluid from within the catheter retention body320 to leave the lumen as fluid enters through the distal lateralfitting 324. In some embodiments, the catheter retaining device 31 mayfurther include one or more one-way purge vents 327 that is capable ofallowing air and fluid to exit the catheter retention body 320.

The proximal portion of the catheter retention body may further includeone or more fittings associated with the catheter. For example, asillustrated in FIG. 3B, in some embodiments, the catheter 340 mayterminate at a catheter fitting 326 provided at a proximal portion ofthe catheter retention body 320. The catheter fitting 326 may provide ameans for introducing fluids into the catheter 340 for delivery to thepatient. As the catheters 340 of various embodiments may have more thanone lumens, a separate catheter fitting may be provided for each lumenof the catheter 340. Thus, the catheter retaining device 320 ofembodiments may have one, two, three, or more catheter fittings 326disposed on a proximal portion of the catheter retention body 320.

In some embodiments, the catheter retaining device 31 may furtherinclude one or more valves positioned to regulate the flow of fluid intoand out of the catheter retention body 320. For example, in someembodiments, valve may be positioned at the distal lateral fitting 324,and in other embodiments, a valve may be positioned at the catheterfitting 326. In still other embodiments, the catheter retaining device31 may include a valve at both the distal lateral fitting 324 and thecatheter fitting 326. In still other embodiments, the catheter retainingdevice 31 may include additional valves located anywhere along thecatheter retention body, 320. For example, valves may be provided withadditional lateral fittings or valves associated with catheter fittings.The valves of various embodiments may be any type of valve known in theart including, for example, gate or slide valves, needle valves, checkvalves, diaphragm valves, butterfly valves, and like. These valves canbe manually controlled or automatically controlled by the injectionsystem to optimize the flow of fluid to and through catheter retentionbody 320 as well as the blood vessel to provide deployment force to thecatheter as the catheter proceeds into veins as well as to ease movementto the central circulation.

In certain embodiments, the catheter retention body 320 may includetexturing or features on an inner surface. Examples of such texturinginclude helical, longitudinal, circumferential grooves, rifling,projections, or other texturing. Texturing may allow a portion of anouter surface of the catheter to contact a portion of an inner surfaceof the catheter retention body 320 to maintain the position of thecatheter in the lumen of the catheter retention body 320 and to providefriction to hold the catheter in place while allowing movement whenacted on with sufficient force. In some embodiments, texturing orfeatures may be provided to regulate and direct the flow of fluidthrough the catheter retention body 320 when the catheter is placedwithin the lumen of the catheter retention body 320. For example,rifling of the inner diameter of the catheter retention body 320 mayallow for directed flow of fluid within the second catheter around thecatheter.

In particular embodiments, the catheter retention body 320 may includeinternal features such as, for example, one or more bulkheads 329 orbaffles 328 positioned at intervals that segment portions of thecatheter retention body 320 or provide currents that can provideadditional pulling force on the catheter. In other embodiments, thebaffles or bulkheads may be positioned to aid in the movement of thecatheter through the catheter retention body by, for example, ensuringthat the catheter is centered within the catheter retention body as itmoves through the catheter retention body. In still other embodiments,the baffles or bulkheads may be positioned to aid in packaging of thecatheter in the catheter retention body.

In certain embodiments, the catheter retaining device 31 may include acentering mandrel 321 sized to be received within a lumen of thecatheter and a mandrel clamp 323 positioned to hold the centeringmandrel at the center of a circumference of the catheter retention body320. In some embodiments, the centering mandrel 321 may be movablyreceived by the mandrel clamp 323 such that the centering mandrel 321may enter the catheter retention body 320 and be retained therein as thecatheter progresses through the blood vessel.

There are several potential benefits to the inclusion of a centeringmandrel 321. It allows for a reduced flow rate of fluid necessary tointroduce the catheter into the blood vessel by reducing the friction ofthe catheter on the catheter retention body 320 inner wall. Thecentering mandrel 321 positions the catheter such that an approximatelyequal amount of fluid flows on either side of the catheter, therebyoptimizing the amount of insertion force exerted on the catheter by thefluid. The centering mandrel may also reduce the tendency of thecatheter to bend or kink. A similar effect may be obtained by providingadditional fluid deployment ports around the circumference of thedeployment tube. Thus, lowered required flow rates may allow forhand-operated syringes to provide adequate fluid flow to insert thecatheter into a patient. The centering mandrel may also provide somecontrolled friction to limit the rate of deployment by sizing of the fitor geometry. To fit within the catheter, the centering mandrel 321 maybe smaller in diameter than the inner diameter of the catheter. Forexample, when used with a second catheter having an inner diameter ofabout 0.008 inches to about 0.035 inches or about 0.01. In this example,the centering mandrel 321 may have a diameter of about 0.008 inches orless.

As illustrated in FIG. 4A, the catheter retention body 420 may bedesigned to receive and package the catheter in any way. For example, insome embodiments, the centering mandrel 421 may be fixedly received bythe mandrel clamp 423, and the catheter 440 may be wound around thecentering mandrel 421. When wound around the centering mandrel 421, thecatheter may be in a single, double coiled, or triple coiledconfiguration. The centering mandrel 421, in such embodiments, mayprovide for improved packaging of the catheter 440 that may allow forthe size of the catheter retention body 420 to be reduced therebyreducing the overall size of the catheter retention device 41.

While the fixed centering mandrel 421 provides a means for winding orcoiling the catheter 440 in the catheter retention body 420, in someembodiments, the catheter may be wound or coiled in the catheterretention body 420 without a centering mandrel. In other embodiments,the catheter may be folded in the catheter retention body 420 asillustrated in FIG. 4B. The shape of the catheter retention body 420 mayreflect the means by which the catheter is stored within the catheterretention body 420. For example, in embodiments in which the catheter iscoiled or wound the catheter retention body 420 may have a substantiallycylindrical, conical, or spherical shape, and in embodiments in whichthe catheter is folded, the catheter retention body 420 may have asquare or rectangular box shape. Coiling the catheter on the innersurface of the catheter retention body 420 and pulling it off the innersurface may provide a compact, low friction deployment mechanism. Inother embodiments, as illustrated in FIG. 4C and FIG. 4D the catheter440 may be coiled upon itself, similar to a ball of twine that can beunwound from the inside out and the catheter retention device 41 mayhave a substantially spherical FIG. 4C or oblong FIG. 4D shape.

Because the catheter 440 can be wound, coiled, or folded within thecatheter retention body 420, the size of the catheter retention body maybe compacted, i.e., shortened in length and larger in diameter therebyimproving the hand ability of the catheter and catheter retention body.For example, in embodiments in which the catheter is not wound orcoiled, the catheter retention body may have a length substantiallyequal to the length of the catheter, for example, from about 20 cm toabout 70 cm or about 25 cm to about 65 cm and a diameter sufficient toreceive a 4 French, 5 French, 6 French, or 7 French catheter. Forexample, the catheter retention body may have a lumen having an internaldiameter of from about 1.5 mm to about 5 mm or about 2 mm to about 4 mm.In embodiments in which the catheter is wound or coiled within thecatheter retention body, the length of the catheter retention body 420may be substantially shortened while the diameter of the catheterretention body 420 may be increased. For example, length L of acylindrical catheter retention body 420 may be about 5 cm to about 50 cmfor a 4 French, 5 French, 6 French, or 7 French catheter having a lengthof about 20 cm to about 70 cm, and in other embodiments, the cylindricalcatheter retention body 420 may have a length of about 10 cm to about 40cm, about 15 cm to about 35 cm, or about 20 cm to about 30 cm, or anyindividual value within these exemplary ranges. Such cylindricalcatheter retention bodies 420 may have an internal diameter D of about10 mm to about 20 cm, about 50 mm to about 10 cm, or any individualvalue within these exemplary ranges. Similar sizes can be achieved forcatheter retention bodies 420 that have square or rectangular boxshapes. For example the length of a rectangular box shaped catheterretention body may be about 10 cm to about 40 cm, about 15 cm to about35 cm, or about 20 cm to about 30 cm, or any individual value withinthese exemplary ranges, and the rectangular box shaped catheterretention body may have a height and width, which can be equal ordifferent, of about 10 mm to about 20 cm, about 50 mm to about 10 cm, orany individual value within these exemplary ranges.

In some embodiments, the catheter may be introduced into the bloodvessel using only the flow of fluid through the catheter retentiondevice 41 and/or the introducer. In other embodiments, the catheterretention device may further include a means for manually orautomatically reeling the catheter out of the catheter retention bodyand/or reeling the catheter back into the catheter retention body as maybe useful during the procedure to provide for optimal final tipplacement. For example, a handle may be disposed on an outer surface ofthe catheter retention body that may facilitate winding or unwinding ofthe catheter around a spindle inside of the catheter retention body 420,and in other embodiments, a motor or motorized wheel, which can beoperated manually or by an injection controller may facilitate windingor unwinding of the catheter within the catheter retention body 420. Themeans for reeling in and reeling out the catheter may allow the deployedcatheter to be retracted, repositioned, or replaced without sacrificingsterility because the catheter will remain enclosed within the catheterretention body throughout the procedure. In other embodiments, thecatheter retention body 420 may include one or more frictionaugmentation devices such as, for example, a pinch valve, iris, or othercompression device that can be pulsed to control the feed-out of thecatheter during insertion. Such friction augmentation devices can becontrolled manually or by a system controller.

The catheters 440 contained within the catheter retention body 420 maybe any type of catheter known in the art. For example, the catheters mayinclude one or more lumens and can be configured as 4 French, 5 French,6 French, or 7 French catheters. In certain embodiments, flow insertionand flow augmentation may allow for catheters having a small diameter, 1French, 2 French, 3 French or as small as PE-10 tubing to be inserted.Such catheters can be configured to deploy any materials known in theart such as, for example, saline, active agents, drugs, medication,nutrients, or other foodstuffs. In some embodiments, the catheter mayinclude a guidewire or other stiffening means that can be used duringdeployment of the catheter and then removed during use. In particularembodiments, catheters contained within the catheter retention body maynot need to include a guidewire or stiffening means. Without wishing tobe bound by theory, the increased blood volume created by thesimultaneous administration of fluid during introduction of the catheter440 may allow the catheter to be deployed without pushing the catheterinto the blood vessel from its proximal end. Alternatively, the amountor amplitude of the primal pushing force can be reduced, while allowingfor manual control by the nurse, providing a “power assist” for thecatheter insertion procedure. The catheter is carried to the deploymentsite by the flow of blood which can be augmented by the flow of fluidand is less likely to kink as a result of portions of the catheter beingpushed past the distal end of the catheter. As such, the need forstiffening means is reduced or eliminated, and moreover, in someembodiments, softer and more compliant materials may be used to make thecatheter. In addition the vessels are dilated or enlarged by theaugmented flow, thereby making insertion easier, less traumatic, andless problematic. Taken together, these improvements provide a catheterintroduction system that is less likely to cause injury to the bloodvessel.

As illustrated in FIG. 5, the catheter 540 incorporated into thecatheter retention devices described above may include features tofacilitate insertion and/or facilitate interactions with the catheterretention device. Generally, the catheter 540 may have a distal end 516configured to be inserted into a blood vessel, and a proximal end 514that may include at least one opening (not shown) capable of allowingfluid to flow into and through the catheter 540 into the patient's vein.The proximal end 514 of the catheter 540 may be designed and configuredto interact with an inner surface of the catheter retention body. Forexample, in some embodiments, a bulge or stopper 519 fixedly attached tothe catheter may be provided at the proximal end of the catheter 540.The bulge or stopper 519 may have any shape. For example, in someembodiments, the bulge or stopper 519 may be round or cylindrical, andin certain embodiments, the bulge or stopper 519 may have a cone shape.The bulge or stopper 519 may be sized to stop the second catheter 540 atan appropriate position within the catheter retention body to ensurethat the catheter does not flow past the deployment site or completelyenter the patient's blood vessel. Thus, in some embodiments, the bulgeor stopper 519 may be sized to approximately equal the inner diameter ofthe catheter retention body and have a larger diameter than the distalfitting of the catheter retention body such that forward movement of thecatheter 540 is stopped when distal fitting is reached.

In some embodiments, the catheter 50 may include marking features 523spaced along the length of the catheter. Such marking features may showthe length of the catheter and can be placed at equally spaced intervalssuch as, for example, each centimeter, each inch, or any suitable unitof measure known in the art. The markings 523 may provide a means forquickly customizing the length of the catheter 50 by cutting thecatheter before it is introduced into the patient. In certainembodiments, the length of the catheter 50 may be determined before thecatheter is packaged in, for example, a catheter retention body, toavoid cutting of the catheter during the introduction procedure. Becausethe catheter retention body is sterile, the sterility of the catheter ismaintained while the catheter is in the catheter retention body,avoiding cutting eliminates the possibility of contamination during theintroduction procedure. Alternatively, catheter may have a standardlength and extra catheter can be pulled back and stored in the catheterretention body providing another means for avoiding cutting during theintroduction procedure and potentially contaminating the catheter beforeintroduction. Having markings extending towards or to the proximal endof the catheter can help in ascertaining that the correct length ofcatheter has been inserted into the patient.

Some embodiments of the invention are directed to catheters. Suchcatheters 50 generally include elongated, unitary, tubular structuremade of a flexible, biocompatible material, such as silicone rubber thatinclude a cylindrical wall 510 defining a longitudinal bore or lumen512, as illustrated in FIG. 5A. In some embodiments, the catheter 50 mayinclude two or more longitudinal bores to provide multiple lumencatheters, and in particular embodiments the catheter may include twoadjacent bores, which may have a substantially “D” shape 513 a, 513 b,in FIG. 5B. The catheters 50 of various embodiments may be sized to havea conventional diameter for catheters designed for insertion into bloodvessels. For example, the catheters of embodiments may be 1 French, 2French, 3 French, 4 French, 5 French, 6 French, or 7 French sizedcatheters having external diameters of about 0.6 mm to about 2.5 mm, orvery thin tubing, such as PE10. The diameter of the lumen may vary basedon the thickness of the sidewalls and the number of lumen associatedwith the catheter.

In some embodiments, the one or more lumens may extend throughout thelength of the catheter 50, and the catheter 50 may have at least oneproximal opening 514 and at least one distal opening 516 through whichfluids can flow into and out of the catheter 50. In other embodiments,the one or more lumens may terminate before the end of the catheter. Forexample, in some embodiments, the catheter may have a proximal opening514 and a sealed or otherwise closed distal end 516, and the lumen mayopen to the blood vessel by one or more lateral slits 518 in thecylindrical wall 510 of the catheter 50 to provide a lateral opening.Such slits 518 may allow the opening to be created when fluid isintroduced into the lumen 512, 513 a, or 513 b, and fluid pressurewithin the lumen may force the lateral slit 518 to open allowing fluidto exit the catheter. When the flow of fluid is stopped and fluidpressure within the lumen is decreased, the slit 518 may close keepingblood or other fluids from entering the catheter when fluid is not beingintroduced into the catheter 50. Similarly, applying suction to thecatheter will open the slit and allow blood to be drawn into thecatheter for sampling as needed. A non-limiting example embodiment is aGroshong catheter.

In certain embodiments, a multi-lumen catheter 50 such as the catheterillustrated in FIG. 5B may include more than one lateral slit. Forexample, as illustrated in FIG. 6, catheter 60 may include a distallateral slit 618 at or near a distal end of the catheter 60, and one ormore additional lateral slits 620. In some embodiments, the additionallateral slit 620 may be positioned at or near a proximal end 614 of thecatheter 60. In other embodiments, additional lateral slits 620 may bepositioned at one or more positions throughout the length of thecatheter 60. In particular embodiments, the catheter 60 of suchembodiments may be a multi-lumen catheter having at least two lumenssuch as the exemplary catheter illustrated in FIG. 5B. The distallateral slit 618 may be associated with a first lumen 513 a, and the oneor more additional lateral slits 620 may be associated with a secondlumen 513 b. Thus, for example, the first lumen 513 a may be configuredto transport an active agent to the distal end 616 of catheter 60, whilethe second lumen 513 b is configured to transport a second active agentfor more proximal administration. In some embodiments, the second lumen513 b having a proximal additional lateral slit 620 may be configured totransport medical fluid or saline that can be introduced into the bloodvessel during introduction of the catheter 60 into the blood vessel, andthe additional saline may act to speed blood flow through the bloodvessel and aid in the movement of the catheter 60 through the bloodvessel. In embodiments in which the catheter 60 includes two or moreadditional lateral slits 620 configured to transport medical fluid,medical fluid may be released over the entire length of the catheterduring introduction of the catheter 60 into the blood vessel. Thecombined local effects of each additional lateral slit may allow forimproved blood flow by increasing blood volume from the site ofinsertion of the catheter 60 to the final deployment site. Holes orslits positioned along the body of the catheter 60 or at a distal end616 of the catheter 60 may allow fluid flow within the vessel to expandthe vessel and ease insertion of the catheter 60 during insertion. Afterintroduction of the catheter 60, medical fluid may continue to beadministered through the additional lateral slits 620, or fluid flow maybe stopped, and in some embodiments, active agents, drugs, medication,nutrients, or other foodstuffs may be administered through the patentthrough the second lumen 513 b and additional lateral slits 620.Proximal slit or opening to deliver CT contrast and prevent rupture ifsofter materials or smaller diameters are used. In some embodiments, theseparation of the proximal and the distal ports may be sufficient toprovide central vascular access for slow or moderate flows through amore atraumatic catheter section or segment and enable proximal accessin a more peripheral vessel for higher or power injected flows.

In some embodiments, the catheter 60 may have a single lumen that hasone or more distal slits or openings for distal delivery and/orwithdrawal as well as normally closed proximal slits or holes fordelivery of drugs at a high rate or pressure which the lumen could notsustain over its whole length. In some embodiments, the catheter mayhave two or more slits arranged proximally. The dimension of the slitsand catheter material stiffness, diameters, and the thickness of thewalls are selected such that they do not open inward under vacuum whenblood is being sampled or under moderate pressures, such as when drugsare being infused slowly, but do open under pressures and flow ratesthat are needed for power injections and would cause a rupture of thecatheter unless that flow were diverted or released into the vessel. Ifthe properties are selected so that the catheter swells controllablyunder the designed pressure, this opens the slits even further andenables increased flow. The geometry and properties of the slits and thecatheter determine the opening pressure, and the number of slitsdetermines the flow rates that can be accommodated at a given pressure.This embodiment can be used with any existing or novel methods ofinsertion, sterile field establishment and other procedural aspects tolimit the need for the majority of the catheter length to experiencehigh pressures when injecting at high flow rates.

In some embodiments, the catheter 50, 60 may have additional coatingssuch as, but not limited to, antibacterial coatings, antifibroticcoatings, or other coatings that can facilitate sterility, ease ofintroduction into the blood vessel, or long-term use in the patient. Insome embodiments, the catheter may be coated with a component or layerprovided to stiffen the catheter 50, 60, and in certain embodiments, atleast one longitudinal bore of the catheter may include a guidewire orother stiffening means removably inserted into the longitudinal bore.Such a guidewire or stiffening means may provide ease of handling of thecatheter 50, 60 during introduction into the blood vessel, and in someembodiments, the guidewire or stiffening means may be removed afterdeployment of the catheter 50, 60. In other embodiments, the cathetermay not include a guidewire or stiffening means. For example, inembodiments in which catheter 60 includes a distal lateral slit 618 at adistal end 616, fluid pressure within the catheter created while thelateral slit is closed may be prevented to reduce or eliminateundulating, flapping, or whipping of the catheter 60 during deploymentof the catheter even for single lumen catheters. Similarly, inmulti-lumen catheters, a first lumen 513 a may be configured to acceptand deploy fluid through a distal port, and a second lumen 513 b may besealed and configured to accept a fluid that is not delivered to thepatient, or have a very small distal opening so that high pressure isdeveloped at modest flow raters. In such embodiments, fluid pressurewithin the second lumen 513 b may sufficiently stiffen the catheter 50so as to reduce or eliminate the need for guidewires or other stiffeningmeans.

The geometry and shape of the catheter body may be designed withstandpressure by incorporating multiple design factors, for example, burststrength of the material and incorporation of reinforcing materials. Toachieve the high flow rates for injecting contrast for imagingprocedures utilizing pressure injections, the catheters need to becapable of withstanding higher pressures, e.g., 300 psi or 325 psi,making these catheters stiffer than catheters that are used for thelower flow rates required for medication infusion and blood withdrawal,e.g., about 10 psi to about 100 psi. In some embodiments, a distalportion of the catheter may be composed of a first material at aproximal end of the catheter capable of withstanding pressures up to 350psi, or about 300 psi to about 325 psi, and a more flexible secondmaterial capable of withstanding pressures up to 100 psi, or from about10 psi to about 100 psi. In other embodiments, the catheter may becomposed of a single material but may be designed to include a firstportion at a proximal end of the catheter having a wall thickness thatis greater than a distal portion of the catheter. The greater thicknessmay allow the proximal portion of the catheter to withstand higherpressures than the distal end of the catheter. Typically, the wallthickness may allow the proximal end to withstand high pressures thanthe distal end of the catheter.

Further embodiments are directed to multi-port introducers and catheterretention devices designed to be used in conjunction with multi-portintroducers. FIG. 7 shows an exemplary multi-port introducer 76 thatincludes an introducer tube 772 having a tapered distal end 774 designedto be introduced into a blood vessel. The proximal end of the introducertube 772 may be operably connected to a multi-port fitting head 776,which may include one or more fittings or ports for connecting withother apparatuses and devices. In FIG. 7, two fittings are provided 780and 781. The introducer tube 772 may be connected to the multi-portfitting head 776 by any means. For example, the multi-port fitting head776 may be an integral part of the introducer tube 772 and, therefore,may be molded with the introducer tube 772. In other embodiments, themulti-port fitting head 776 may be molded separately and fixedlyattached to the introducer tube 772 using, for example, an adhesive, oneor more connectors, or any other connector means known in the art orcombinations thereof. In some embodiments, the introducer tube 772and/or the multi-port fitting head 776, or portions thereof, may includeone or more Venturi features 778.

The introducer tube 772 may have any inner diameter sufficiently sizedto accommodate the catheter. For example, the introducer tube 772 mayhave an inner diameter sufficient to accommodate a 4, 5, 6, or 7 Frenchcatheter. In some embodiments, the introducer tube 772 may be an 18gauge catheter having an inner diameter of about 0.051 inches. In someembodiments, the introducer tube 772 may be sized such the lumen andopening in the distal end 774 of the introducer tube 772 providesufficient space to allow fluid delivery through the introducer tube 772during deployment of the catheter. Thus, fluid delivery can occursimultaneously with deployment of the catheter. In other embodiments,the distal end 774 of the introducer tube 772 may be sized to fitsnuggly around the catheter during deployment, and simultaneous fluiddeployment may be carried out through one or more holes or apertures inthe introducer tube 772 that are positioned to allow fluid to flow fromthe introducer tube 772 into the blood vessel while the catheter isbeing deployed.

In some embodiments, the multi-port introducer 76 may include a Venturifeature 778 disposed between the multi-port fitting head 776 and theintroducer tube 772 that is designed and arranged to interact with thecatheter during deployment of the catheter. The Venturi feature 778 maygenerally have a substantially conical shape sized and configured toreduce the inner diameter of the multi-port fitting head 776. Inaddition, the Venturi feature may be designed to increase the velocityof the fluid and thus the force pulling the catheter into the vein orreduce drag caused by the flow of fluid and friction created when thecatheter contacts an inner surface of the Venturi feature 778 duringinsertion.

The multi-port fitting head 776 may include any number of ports orfittings, and as illustrated in FIG. 7, the exemplary multi-port fittinghead 776 includes a first fitting 780 and a second fitting 781. Suchfittings may be any type of fittings known in the art and may beconfigured to removably attach to any component known in the art. Forexample, in some embodiments, the fittings may be luer or screw typefittings, which may be configured to attach to, for example, commonlyused IV tubes or syringes. In other embodiments, the fittings may beconfigured to attach directly to other medical devices such as, but notlimited to, endoscopes. In still other embodiments, the fittings may besimple pressure fittings or other tube connectors.

The multi-port introducer 76 may be designed to be implanted into apatient in the same way as a typical angiocatheter such as theangiocatheter illustrated in FIG. 1. Therefore, the multi-portintroducer 76 may include a number of peripheral parts that are presentwhen the introducer is packaged but that can be removed after insertioninto a blood vessel. For example, in certain embodiments, the multi-portintroducer 76 may include a cap 782 designed to operably connect to andclose off the second fitting 781, and a cap 783 designed to operablyconnect to and close off the first fitting 780. In particularembodiments, the multi-port introducer 76 may include a needle assembly78 sized and configured to be received within a lumen of the multi-portintroducer 76. The needle assembly may generally include a needle 784sized such that the distal pointed end 786 of the needle extends beyondthe tapered distal end 774 of the introducer tube 772 when the needle784 is received in the multi-port introducer 76. The needle assembly 78may further include a fitting or stopper 788 designed and configured tooperably connect to at least a portion of the multi-port introducer 76and hold the needle in place within the multi-port introducer 76. Insome embodiments, the fitting or stopper 788 may be held in place usingsimple pressure fittings, and in other embodiments, the fitting orstopper 788 may include a luer or screw-type fitting used to hold theneedle assembly 78 on place during insertion into the blood vessel. Inoperation, the needle assembly 78 may provide sharp edges forfacilitating entry into the blood vessel and through the skin. After themulti-port introducer 76 has been introduced into the blood vessel, theneedle assembly may be removed leaving the multi-port introducer 76 inthe blood vessel and providing an entry point into the blood vessel andcirculatory system.

The first and second fittings 780, 781 may be initially covered usingcaps such as cap 782, 783 in FIG. 7, and various common connectors maybe used to connect the multi-port introducer to, for example, IV tubingor other medical devices. Therefore, a multi-port introducer may be usedfor introduction of fluids, medicaments, drugs, active agents,nutrients, and other fluids like a common angiocatheter.

In particular embodiments, as illustrated in FIG. 8, the multi-portintroducer 86 may be designed to link to a catheter retention device 81such as those described herein. For example, in some embodiments, thesecond fitting 881 may be a luer or screw type fitting capable ofattaching to a fluid source or tubing associated with a fluid source890, and the first fitting 880 may be configured to removably attach toa catheter retention device 81. The catheter retention device mayinclude any of the elements described herein and can associate with themulti-port introducer 86 through a distal fitting 822. The catheterretention body 820 may house a catheter which is wound, coiled, folded,or otherwise retained in the catheter retention body 820, such that adistal end of the catheter may enter the multi-port introducer 86through the first fitting 880 and enter a blood vessel through thetapered distal end 874 of the introducer tube 872. The catheter may becarried into and through the blood vessel by fluid introduced intomulti-port introducer the second fitting 881.

Alternatively, the fitting 880 may be fitted with a “Y” fitting. Acatheter may be inserted through one of the ports and the other can beused for delivering drugs as subsequently needed. In addition, thesecond Y-port could be used for insertion of another catheter with asimilar or different length for injection of different fluids. MultipleY-ports can be used as needed provided that the catheters are smallenough to fit through the introducer. This has the benefit of being ableto provide an additional lumen without having to make another IV stickin the patient or remove and existing catheter and introduce a new one.

In some embodiments, fluid flow from the second fitting 881 of themulti-port introducer 86 may be sufficient to carry the catheter intoand through the blood vessel without introducing additional fluidthrough other ports. In other embodiments, the catheter retention device81 may include one or more fittings capable of attaching to a fluidsource and providing additional fluid that will flow through thecatheter retention device 81 and multi-port introducer 86 to carry thecatheter into the blood vessel. For example, in some embodiments,catheter retention device 81 may include one or more distal lateralfittings 824 a and one or more proximal lateral fittings 824 b throughwhich fluid may enter the catheter retention body before flowing intothe multi-port introducer 86 and into the blood vessel. The catheterretention device 81 may further include one or more purge vents 826 forreleasing air trapped in the catheter retention body 820.

The at least one portion of the multi-port introducer 86 may, generally,be sized to hold the catheter in place after deployment and may providea seal around the outer circumference of the catheter to block flow ofblood or other fluids from the introducer tube 872 into the catheter.For example, a seal may be provided at a junction between the introducertube 872 and the Venturi feature 878 or the multi-port fitting head 876.The proximal end of the catheter may remain in a portion of the firstfitting 880 such that the proximal open end of the catheter can beaccessed through the first fitting 880. In some embodiments, the firstfitting 880 may configured to hold the proximal end of the catheter in aspace within the first fitting 880. For example, in certain embodiments,the first fitting 880 may include a conical or spherical cavity at aproximal end of the fitting sized to receive and hold an end of thecatheter. A clamp or other means for holding the catheter in the cavitymay be provided at a distal end of the cavity to hold the proximal endof the catheter in place within the cavity while allowing the lumen ofthe catheter to remain free from obstruction. In some embodiments, theclamp may be a manual clamp. In operation, the catheter may be deployedfrom a catheter retention device through a multi-port introducer andinto a blood vessel, and a clamp on the multi-port introducer may beengaged to fixedly hold the catheter in the multi-port injector. Thecatheter retention device may then be removed from the multi-portintroducer with a length of catheter remaining in the catheter retentiondevice, and the catheter may be cut near the multi-port introducerfreeing the catheter retention device while leaving the catheter inplace for the administration of medical fluids. Alternatively, the extralength of catheter may be coiled and attached to the patient's limb orbody, or may be retained in the catheter retention device and thecatheter retention device is attached securely and sterilely to thepatient's limb or body.

In certain embodiments as illustrated in FIG. 7, the first fitting 780may further include a cap 783 configured to seal the first fitting 780and eliminate fluid flow through release of fluid from the multi-portintroducer 76 after the catheter has been deployed. The cap 783 may beplaced or replaced over the catheter after it has been deployed toprotect the catheter from contamination when not in use. In suchembodiments, the catheter may be deployed using the catheter retentiondevice, and the catheter retention device can be removed while thecatheter remains deployed in the blood vessel.

In particular embodiments, the multi-port introducer may be configuredto be removed from the blood vessel following deployment of thecatheter. For example, in some embodiments, the introducer tube of themulti-port introducer may be splittable such that following deploymentof the catheter, the introducer tube may be removed by breaking theintroducer tube along a longitudinal axis and removing the remaininghalves from the insertion site. In such embodiments, the multi-portfitting head may remain associated with and/or attached to the catheter.In some embodiments, the catheter retention body may be attached to themulti-port fitting head, and in other embodiments, the catheterretention body may be removed before or after the introducer tube isremoved.

In those embodiments where the introducer remains in the body, thedistal end in the vessel through which the more distally deployedcatheter exits is an important aspect of this invention. If theintroducer is a standard angiocath, the catheter is a relatively stiffmaterial and the distal opening of the angiocatheter is of a relativelyfixed diameter. This means that fluid can be injected around thecatheter, and that there is the possibility for clot formation overtime. Alternatively, the introducer or distal end of the introducer ofthis invention can be made of silicone or other relatively elastomericmaterial such that it is opened by the flow of fluid to transmit thecatheter distally, and then closed to seal against the outer diameter ofthe catheter when flow is absent. By closing to reduce or eliminate theingress of blood, the likelihood of clot formation in the introducerlumen is significantly reduced. To inject fluids through the introducerand into the patient, applying sufficient pressure will expand theintroducer and conduct the fluid into the patient's vessel.Alternatively, slits or other openings may be provided in the wall ofthe introducer to transmit the injected fluid into the patient'svessels.

The multi-port introducers of various embodiments may include any numberof additional features provided to facilitate ease of use or provideimproved control of fluid flow through either the introducer tube or acatheter extending through the multi-port introducer. For example, insome embodiments, the introducer tube may include one or more dischargeports 990 that can be adjusted using a discharge button 991 located on amore distal portion of the multi-port introducer 96. The discharge port990 may, generally, be one or more lateral openings such aslongitudinally adjustable slits or variable window apertures that arepositioned on a portion of the introducer tube 972. The discharge button991 may twist or slide to be activated and may increase the flow offluid into the blood vessel by allowing fluid from the multi-portintroducer 96 to exit through the discharge ports 990 whilesimultaneously reducing the amount of fluid passing over the catheterthus slowing the deployment rate of the catheter.

In some embodiments, the multi-port fluid port may further include acompression brake and adjustable iris located between the first fittingand the introducer tube designed and configured to contact the catheterand slow the rate of deployment by way of friction as the catheter isdeployed by depressing the brake or iris. The Venturi iris can beconstructed to either compress inward or rotate around the body of thecatheter. When activated, the opening of the Venturi iris widens andreduces the pressure drop between the inflow and out flow regions andreducing the force by the fluid flow applied to the catheter.

The various portions of the devices described above, including theangiocatheter or multi-port introducer and the catheter retention devicemay be combined to provide a single device, or in some embodiments, eachelement may be separate devices that are assembled during use. In otherembodiments, the various components may be combined in a kit includingone or more angiocatheters, one or more multi-port introducers, one ormore catheter retention devices, fittings, tubing, and other componentsthat may be useful for introducing a catheter into a blood vessel usingthe devices described above, and any combination of such components. Asmentioned above, in various embodiments, the catheter may bepre-assembled, sterilized, and sealed in the catheter retention body ofthe catheter retention device. The catheter can remain inside a sterilecontainer or package until it is inserted into the patient, so that thesterile field need not be much larger than that of a simple IV catheter(which typically involves just washing around the introduction site).

In some embodiments, the catheter may be processed before being packagedinto the catheter retention body or the catheter may be packaged withadditional components that may ease introduction of the catheter orprovide other improvements. For example, in certain embodiments, alubricant may be included in the sterile packaging to reduce anypotential friction during deployment of the catheters. Similarly, acoating designed to reduce friction during deployment may be applied tothe catheters during or prior to packaging.

Various embodiments are directed to methods for deploying a catheter. Ingeneral such methods include introducing a catheter into a blood vesselat an introduction site and simultaneously introducing a fluid into theblood vessel at the introduction site. In certain embodiments,simultaneous introducing of the catheter and fluid at a commonintroduction site can be carried out using a multi-port introducer suchas those described above. In other embodiments, a multi-port introducerand a catheter retention device or a catheter retention device and acommon angiocatheter can be used to simultaneously introduce a catheterand fluid into a blood vessel at a common introduction site. Withoutwishing to be bound by theory, the introduction of fluid with thecatheter may allow the catheter to be carried through a blood vesselwith the flow of blood through the blood vessels to the deployment sitewhere it can be used for the deployment of drugs or other medical fluidswithout providing an external pushing force. The fluid flowing into theblood vessel may increase the blood volume and enlarge or distend theblood vessels to improve blood flow and assist in movement of thecatheter through the blood vessels. Therefore, embodiments of themethods may be used for deployment of catheters through veins, whichgenerally exhibit weaker blood flow, as well as arteries, and in certainembodiments, the methods may be directed specifically to introducing acatheter into a vein.

The flow rate and volume of fluid introduced during delivery of thecatheter may vary among embodiments and may depend on various factorsincluding, for example, restraining forces, the size of the catheter,the distance from the insertion site the catheter must travel for properplacement, the size of the vessels, amount of flex or expansion desiredby the walls of the vein into which the catheter is being introduced,and the like and combinations thereof. In general, the flow rate shouldbe sufficient to urge the catheter through the patient's vein andthrough any insertion apparatus such as an angiocatheter, a multi-portintroducer, or either an angiocatheter or a multi-port introducer and acatheter retention device. In some embodiments, the flow rate may besufficient to enlarge or distend the blood vessel, which may facilitateinsertion of the catheter into the blood vessel, and in furtherembodiments, the flow rate may be sufficient to augment the flow of theblood in the blood vessel. For example, the flow rate may be faster thanthe flow of blood such that that the flow of fluid from the insertionapparatus creates or augments the forward or distally directed force onthe catheter.

The flow rate may further off set restraining forces. As used herein,“restraining force” may be any force that slows or could slow movementof the catheter into the blood vessel. For example, restraining forcescan be created by the friction as the catheter moves through aninsertion apparatus such as an angiocatheter, a multi-port introducer,or either an angiocatheter or a multi-port introducer and a catheterretention device. Restriction forces further include manual restraint ofthe catheter caused by friction as the catheter is removed from astorage container or uncoiled from a spool. Limiting the play out ofcatheter, for example, a motion controlled or motion limited spool canalso be considered a source of restraining force. Still other sources ofrestraining force include handling of the catheter by the clinician asit is introduced into the insertion apparatus. Further sources ofrestraining forces include for example, pinch clamps or friction wheels.

In some embodiments in which the catheter is deployed through anangiocatheter or a multi-port introducer, the angiocatheter ormulti-port introducer may be removed from the insertion site afterdeployment. In other embodiments, the angiocatheter or multi-portintroducer head may remain inserted into the blood vessel afterdeployment and may continue to be used for delivery of fluids into theblood vessel. For example, in some embodiments, methods may include thesteps of introducing or deploying a catheter into a blood vessel throughan angiocatheter or multi-port introducer and introducing fluid throughthe angiocatheter or multi-port introducer after deployment of thecatheter. In some embodiments, the fluid introduced into the bloodvessel after deployment may be saline, nutrient fluids such as glucose,or other medical fluid that can be continually introduced into apatient. In other embodiments, the angiocatheter or multi-portintroducer may be used for locally delivering fluids such as, forexample, contrasting agents for scans or other tests, or drugs or otheractive agents, or combinations of these with saline or other medicalfluids. In certain embodiments, anti-fibrotic agents may be administeredthrough the angiocatheter or multi-port introducer, and theanti-fibrotic agent may wash over the catheter mitigating the fibroticresponse and reducing fibrous tissue deposits on the external surface ofthe catheter to reduce thrombosis or catheter occlusion. Therefore, thecatheter may remain in place for a longer period of time than cathetersthat do not remain associated with an angiocatheter or multi-portintroducer that allows for fluid to be introduced at an insertion sitewhile a catheter is in place at the insertion site.

More particular embodiments include the steps of inserting anangiocatheter or multi-port introducer into a blood vessel, and in someembodiments, securing the angiocatheter or multi-port introducer usingstandard means such as taping to the patient's skin with medical tape.The method may include connecting the angiocatheter or multi-portintroducer to a fluid source and providing a flow of fluid through theangiocatheter or multi-port introducer. Providing fluid flow may beaccomplished by any means. For example, in some embodiments, fluid flowmay be provided using saline from an IV bag and associated tubing thatrelies on gravity. In other embodiments, fluid flow may be provided by apump that pushes or pumps fluid from a reservoir through theangiocatheter or multi-port introducer. In still other embodiments, flowof fluid may be provided using a syringe or other manual device. Acatheter may then be inserted into the angiocatheter or multi-portintroducer while simultaneous fluid flow is maintained through theangiocatheter or multi-port introducer. The catheter is carried by theflow of fluid through the angiocatheter or multi-port introducer andthrough the blood vessels by the fluid flow.

In some embodiments, the step of inserting a catheter into theangiocatheter or multi-port introducer can be facilitated with acatheter retention device such as those described above. In suchembodiments, after inserting the angiocatheter or multi-port introducerinto the blood vessel, the method may include attaching a catheterretaining device housing a catheter to the angiocatheter or multi-portintroducer and initiating a flow of fluid through the angiocatheter ormulti-port introducer, the catheter retaining body, or both. The flow offluid may then carry the catheter into the blood vessel effectingdeployment of the catheter.

In certain embodiments, the catheter retention device may include anumber of fittings or purge vents. Referring to the catheter retentiondevice of FIG. 3A, for example, such methods may include operablyconnecting the catheter retention body 31 to the angiocatheter ormulti-port introducer, opening a purge vent 327 on a catheter retentionbody 320, and filling the catheter retention body 320 with fluid. Asfluid is introduced into the catheter retention body 320, air frominside the catheter retention body 320 can be pushed out through thepurge vent 327 thereby removing air from the catheter retention body320. When fluid begins flowing through the purge vent 327, the purgevent 327 may be closed, and further fluid introduced into the catheterretention body 320 can flow into the angiocatheter or multi-portintroducer carrying the catheter from the catheter retention body 320into the angiocatheter or multi-port introducer and into the bloodvessel. In some embodiments, deployment of the catheter may stop whenthe a bulge or stopper associated with a proximal end of the catheterreaches a position on the catheter retention device, angiocatheter, ormulti-port introducer that cannot allow the bulge or stopper to pass.

After deployment of the catheter, the catheter retention device may beremoved from the angiocatheter or multi-port introducer, and in someembodiments, the catheter may be secured to the angiocatheter ormulti-port introducer using a cap. The catheter may be accessed asnecessary by removing the cap or attaching a delivery device through thecap. As discussed above, fluids such as saline, active agents, drugs, orcontrast agents can be introduced into the patient through the catheterwhile the angiocatheter or multi-port introducer remains in place, andsaline, active agents, drugs, or contrast agents can be introduced intothe blood vessel through the angiocatheter or multi-port introducerwhile the catheter remains in place. In various embodiments, thecatheter may be sized to be positioned at a specific location within thebody of the patient such as near a particular organ or injury, forexample, near the patient's heart to effectuate localized delivery ofthe active agent, drug, or contrast agent introduced through the secondcatheter.

While the catheter and deployment system described herein can beoperated manually using existing discrete ancillary devices andequipment such as angiocatheters, ultrasound imagers, and hand heldsyringes with saline, there can be a benefit in standardization of careand ease of use that comes with using an integrated electromechanicalsystem. FIG. 9 shows a system that can be used to deploy the cathetersof various embodiments. Such systems 90 may include, for example, asystem controller 902, electronically connected to one or more pumps 904that can be fluidly connected to a fluid reservoir 901 or other sourceof injectable fluid. The system controller 902 may be configured toreceive information about the catheter 940, catheter retention body 91,and insertion device, the patient, the procedure, and other parametersto determine the volumes and flow rates to be delivered over time. Inaddition, the system controller 902 may receive information from a userinterface 908, information tags on devices connected to the systemcontroller such as RFID tags or bar codes 910, wifi or other internetlinks to hospital information systems 912, or combinations thereof.

In some embodiments, information about the catheter, catheter retentionbody, and insertion device, the patient, the procedure, and otherparameters may be received by the control system 902. For example, thecontrol system 902 may be operably connected to the catheter retentionbody 91 through one or more catheter play-out monitors 9022 on, one ormore flow port monitors 9024 associated with fluid ports 924, pressuresensors 9026 on an inner surface of the catheter retention body 91, andlike and combinations thereof. In some embodiment, the system 90 mayfurther include a tip location monitor 9032 or measurement system 9034associated with the catheter 940. A wide variety of tip location methodsare currently used and can be incorporated into the systems ofembodiments. In certain embodiments, the system 90 may use informationreceived from a play-out monitor 9022 or measuring device 9034 and a tiplocation monitor 9032 to control the fluid flow by modulating the pump904 or operating friction augmentation devices on the catheter retentionbody 91. The information may be used by the operator and/or a computerprogram to optimize the tip location. In some embodiments, the tiplocation can be verified via a method such as a chest X-ray followingdeployment, and the tip location can be adjusted using the system if thedeployment system 90 has not been removed. Alternatively, the cathetercan be pulled back or moved forward if sterility has been maintained.

It will be appreciated that various of the above-disclosed and otherfeatures and functions, or alternatives thereof, may be desirablycombined into many other different systems or applications. It will alsobe appreciated that various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art which are also intended tobe encompassed by the disclosed embodiments. If not otherwise statedherein, it may be assumed that all components and/or processes describedheretofore may, if appropriate, be considered to be interchangeable withsimilar components and/or processes disclosed elsewhere in thespecification, unless an express indication is made to the contrary.

What is claimed is:
 1. A catheter retention device comprising: acatheter retention body having a proximal end and a distal end, thecatheter retention body defining a lumen designed and configured toreceive a catheter; a fluid source that provides a fluid at a fluid flowrate which is greater than a flow of blood in a vein; one or moreproximal fittings operably connected to the catheter, and providingfluid communication from an exterior of the catheter retention body toan interior of the catheter; at least one distal lateral fitting on adistal portion of the catheter retention body, the at least one distallateral fitting being designed and configured to couple to the fluidsource and introduce the fluid into a distal portion of the lumen of thecatheter retention body; a distal fitting at the distal end of thecatheter retention body, the distal fitting defining a distal aperturethrough which the fluid and the catheter exit the lumen of the catheterretention body, wherein the fluid flowing through the distal apertureprovides substantially all of a force required to expel the catheterfrom the catheter retention body and provides a pulling force on thecatheter in a venous blood vessel related to the fluid flow rate and theflow of blood in the vein, wherein the fluid provides an augmented fluidflow rate in the venous blood vessel; and at least one frictionaugmentation device positioned to contact the catheter received withinthe lumen of the catheter retention body, wherein the at least onefriction augmentation device provides a restraining force on thecatheter during catheter deployment to control a rate of feed-out of thecatheter from the distal aperture of the catheter retention body so therate of feed-out of the catheter is less than the augmented fluid flowrate in the venous blood vessel.
 2. The catheter retention device ofclaim 1, further comprising the catheter contained within the lumen ofthe catheter retention body.
 3. The catheter retention device of claim2, wherein the catheter is wound, coiled, or folded in the lumen of thecatheter retention body.
 4. The catheter retention device of claim 2,wherein the catheter is composed of a soft flexible material.
 5. Thecatheter retention device of claim 2, wherein the catheter does notinclude a guidewire.
 6. The catheter retention device of claim 1,further comprising one or more purge vents disposed on the catheterretention body.
 7. The catheter retention device of claim 1, wherein theat least one distal lateral fitting and the distal fitting are selectedfrom the group consisting of screw fittings, luer fittings, pressurefittings, snap fittings, and combinations thereof.
 8. The catheterretention device of claim 1, further comprising one or more valvesselected from the group consisting of gate or slide valves, needlevalves, check valves, diaphragm valves, butterfly valves, andcombinations thereof positioned to regulate fluid flow into and throughthe lumen of the catheter retention body.
 9. The catheter retentiondevice of claim 1, further comprising one or more baffles, bulkheads,and combinations thereof disposed within the lumen of the catheterretention body.
 10. The catheter retention device of claim 1, furthercomprising texturing features on an inner surface of the catheterretention body, wherein the texturing features are selected from thegroup consisting of helical grooves, longitudinal grooves,circumferential grooves, rifling, projections, and combinations thereof.11. The catheter retention device of claim 1, further comprising: acentering mandrel sized to be received within the lumen of the catheterretention body; and a mandrel clamp positioned to hold the centeringmandrel at a center of a circumference of the catheter retention body.12. The catheter retention device of claim 11, wherein the centeringmandrel is sized to be received within a lumen of the catheter.
 13. Thecatheter retention device of claim 1, wherein the at least one frictionaugmentation device is a pinch valve, an iris, a compression device, ora combination thereof.
 14. A catheter retention device comprising: acatheter retention body having a proximal end and a distal end, thecatheter retention body defining a lumen designed and configured toreceive a catheter; a catheter contained within the lumen of thecatheter retention body, wherein the catheter is composed of a softflexible material and comprises a proximal end and a distal end; a fluidsource that provides a fluid at a fluid flow rate which is greater thana flow of blood in a vein; one or more proximal fittings operablyconnected to the proximal end of the catheter, and providing fluidcommunication from an exterior of the catheter retention body to aninterior of the catheter; at least one distal lateral fitting on adistal portion of the catheter retention body, the at least one distallateral fitting being designed and configured to couple to the fluidsource and introduce the fluid into a distal portion of the lumen of thecatheter retention body; a distal fitting at the distal end of thecatheter retention body, the distal fitting defining a distal aperturethrough which the fluid and the catheter exit the lumen of the catheterretention body, wherein the fluid flowing through the distal apertureprovides substantially all of a force required to expel the catheterfrom the catheter retention body and provides a pulling force on thecatheter in a venous blood vessel related to the fluid flow rate and theflow of blood in the vein, wherein the fluid provides an augmented fluidflow rate in the venous blood vessel; and at least one frictionaugmentation device positioned to contact the catheter received withinthe lumen of the catheter retention body, wherein the at least onefriction augmentation device provides a restraining force on thecatheter during catheter deployment to control a rate of feed-out of thecatheter from the distal aperture of the catheter retention body so therate of feed-out of the catheter is less than the augmented fluid flowrate in the venous blood vessel.
 15. The catheter retention device ofclaim 14, wherein the catheter is wound, coiled, or folded in the lumenof the catheter retention body.
 16. The catheter retention device ofclaim 14, further comprising one or more purge vents disposed on thecatheter retention body.
 17. The catheter retention device of claim 14,further comprising one or more valves selected from the group consistingof gate or slide valves, needle valves, check valves, diaphragm valves,butterfly valves, and combinations thereof positioned to regulate fluidflow into and through the lumen of the catheter retention body.
 18. Thecatheter retention device of claim 14, further comprising one or morebaffles, bulkheads, and combinations thereof disposed within the lumenof the catheter retention body.
 19. The catheter retention device ofclaim 14, further comprising: a centering mandrel sized to be receivedwithin the lumen of the catheter retention body; and a mandrel clamppositioned to hold the centering mandrel at a center of a circumferenceof the catheter retention body.
 20. The catheter retention device ofclaim 14, wherein the at least one friction augmentation device is apinch valve, an iris, a compression device, or a combination thereof.21. The catheter retention device of claim 1, wherein the fluid flowrate is sufficient to enlarge a diameter of the venous blood vessel. 22.The catheter retention device of claim 14, wherein the fluid flow rateis sufficient to enlarge a diameter of the venous blood vessel.